Dexmethylphenidate HCl Extended-Release — Class III drug recall D-1430-2015
Terminated recall by Novartis Pharmaceuticals Corp., reported 2015-09-23, distributed in NJ. Failed Dissolution Specifications: Product is being recalled due to out of specification (above specification)
| Recall number | D-1430-2015 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Novartis Pharmaceuticals Corp., Suffern, NY, United States |
| Recall initiated | 2015-07-28 |
| Classified | 2015-09-14 |
| Reported by FDA | 2015-09-23 |
| Terminated | 2017-05-10 |
| Distributed | NJ |
| Quantity | 10,767 bottles |
| Reason classes | specification failure |
| Lot numbers | F0002 |
| Expiration dates | 2016-12 |
Product
Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules. Manufactured by Alkermes Gainesville LLC Gainesville, GA 30504 for Sandoz Inc. Princeton, NJ 08540
Reason for recall
Failed Dissolution Specifications: Product is being recalled due to out of specification (above specification) result obtained at 6-hour dissolution time point during the 12-month stability testing.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1430-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.